Pain Horizon Scan June 2011 - Keele University

Written by Nadia Corp for: © Arthritis Research UK 2011

1

HORIZON SCANNING: MUSCULOSKELETAL PAIN DISORDERS

UPDATE – JUNE 2011

The object of these Horizon Scanning reports is to highlight recently completed and ongoing

clinical trials, research recommendations and new and emerging health technologies. This follow

up report includes trials registered since June 2008 together with research recommendations for

guidelines published since June 2008.

Details of all material included in this report are shown in the appendix, sorted according to

anatomical region involved. Further details of each study can be obtained via the links given to the

relevant webpage.

CONTENTS

SEARCH METHODOLOGY 3

RESULTS 4

ABBREVIATIONS 5

APPENDIX 6

A: Clinical Trails 6

A1: Hand, Wrist, Finger & Thumb pain………………………………………………. 6

Behavioural, education & exercise including physiotherapy 6

and manual therapy

Device 7

Dietary supplements 7

Drugs including biologics 7

Miscellaneous observational studies 8

A2: Elbow pain ……………………………………………………………………………….. 8


Device 9

A3: Shoulder pain ……………………………………………………………………………….. 9


and manual therapy


2

Procedures 10

Others including CAM therapies 11


A4: Neck pain ……………………………………………………………………………….. 12


and manual therapy


Procedures 15

Other including CAM therapies 16

A5: Back pain…………………………………………………………………………………. 17


and manual therapy

Device 20




Procedures 25


A6: Hip pain ……………………………………………………………………………….. 28


and manual therapy

A7: Knee pain ……………………………………………………………………………….. 28


and manual therapy

Dietary supplement 29

Device 29

A8: Foot, Ankle & Toe pain ………………………………………………………….. 30


and manual therapy

Device 31




3

A9: Fibromyalgia ……………………………………………………………………………….. 33


and manual therapy

Device 34





A10: Chronic pain ………………………………………………………………………………. 38


and manual therapy

Device 39



A11: Pain …….………..……………………………..……………………………………. 41


and manual therapy

Device 42

Dietary Supplement 42




B: Research Recommendations 46

REFERENCES 51

SEARCH METHODOLOGY

Databases Searched

Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; German Clinical Trials Register;

ISRCTN register; MRC Clinical Trials Unit; Nederlands Trials Register; UKCRN Portfolio Database.

Keywords searched

Hand pain; Wrist pain; Finger pain; Thumb pain; [Meta]carpal pain; Phalangeal pain; Elbow pain;

Epicondylitis; Tennis/Golfer’s Elbow; Shoulder pain; Neck pain; Cervical pain; Back pain; Sciatica;

Sacroiliac pain; Hip pain; Knee pain; Ankle pain; Foot pain; Toe pain; [Meta]tarsal pain; Chronic

[widespread] pain; Fibromyalgia; Pain (as a [musculoskeletal] condition); Musculoskeletal pain.

4

Keywords and phrases were used separately or in combination; truncation was used where

possible/applicable.

Note: in the case of the Australian New Zealand Clinical Trials Registry the joint/anatomical region

was always searched for under the category of musculoskeletal.

Conditions excluded from this search

1. Surgical interventions and subsequent rehabilitation programmes, except when

compared to non-surgical interventions

2. Peri- and post-operative pain

3. Pain resulting from trauma e.g. fracture, dislocation, rotator cuff tears and whiplash

4. Pain primarily associated with a non-musculoskeletal condition e.g. pelvic pain,

cancer-related pain, infection, pregnancy, hemiplegic/post-stroke etc. including

somatoform pain

5. Pain syndromes e.g. Patellofemoral Pain Syndrome

6. Neuropathic pain

7. Headache

8. Facial pain including Temporomandibular Joint disorders

9. Pain associated with osteoarthritis of the knee or hip (except for research

recommendations from guidelines): these areas attract a substantial amount of

research and are included in the Osteoarthritis and related disorders CSG’s Horizon

Scanning report, available via the Arthritis Research UK website. Note however,

pain associated with osteoarthritis of other joints and in general is included in this

report.

Date limits

This report includes trials that were registered from June 2010 onwards including those completed

since June 2008.

RESULTS

A: Clinical Trials

Since December 2010, 208 completed or ongoing clinical trails were identified for musculoskeletal

pain: these are tabulated in the appendix divided into anatomically distinct sections:

A1: Hand, Wrist, Finger and Thumb pain (n = 12);

A2: Elbow pain (n = 2);

A3: Shoulder pain (n = 15);

A4: Neck pain (n = 24);

A5: Back pain (n = 60);

A6: Hip pain (n = 1);

A7: Knee pain (n = 7);

A8: Foot, Ankle and Toe pain (n = 9);

A9: Fibromyalgia (n = 29)

A10: Chronic pain (n = 20);

A11: Pain (n = 26);

5

For clarity each section is subdivided according to type of intervention: behavioural, device,

dietary supplement, drug, other interventions and miscellaneous observational studies, within

which clinical trials are ordered by completion date. Unless otherwise stated in the table trials

involve participants of both genders. Each clinical trial has a weblink which can be followed for

further details of the study.

In the general pain section (A11), diagnosed rheumatic conditions were only included when the

focus of the study was pain associated with the pathology as opposed to the treatment of the

disease as a whole (this is particularly pertinent to the drug/biologic trials).

B: Research Recommendations

Recent, current clinical guidelines (June 2008 onwards) pertaining to musculoskeletal pain,

including osteoarthritis, are reported in Section B of the appendix with any corresponding

research recommendations or specialist adviser comments (NICE) detailed.

ABBREVIATIONS

Adt Adt (18-65 years)

CAM Complementary and Alternative Medicine

CBT Cognitive Behavioural Therapy/Treatment

Child Child (<18 years)

Comp Completed

CT ID Clinical Trials Identifier

F-only Female only

Grps Groups

Invite Invite only

M-only Male only

n Enrollement

N/K Not known

OA Osteoarthritis

RA Rheumatoid arthritis

Rec Recruiting

Recruit Recruitment

Sen Senior (>65 years)

6

A: CLINICAL TRIALS

Clinical trials identity number (CT ID): Prefix of NCT denotes National Clinical Trials Identifier; ISRCTN - International Standard Randomized Controlled Trial

Number; UKCRN – UK Clinical Research Network; ACTRN – Australian New Zealand Clinical Trials Registry; NTR – Nederland Trial Register; DRK – German clinical

Trials Register; UMIN – University Hospital Medical Information Network; JMA - Japan Medical Association Center for Clinical Trials Register; JapicCTI - Japan

Pharmaceutical Information Center Clinical Trials Identifier. Note: Where no end date was given the following were used: completion date for primary outcome

measure – italics; last update – preceeded with a ?; start date + final timepoint of outcomes – preceeded with a >.

A1: HAND, WRIST, FINGER & THUMB PAIN

Title Phases: study design (control) CT ID

Interventions Conditions Recruit n Age Grp

Start Date

End Date

Sponsors URL

Behavioural, education & exercise incl. physiotherapy & manual therapy

Effect of exercises for persons with Hand OsteoArthritis. RCT (active) ISRCTN79019063

Hand exercise; treatment as usual (no exercise)

Hand OA Ongoing 80 Adt Sen

Feb-11 Jun-14 Martina Hansens Hospital (Norway)

http://www.controlled-trials.com/ISRCTN79019063

A randomised controlled trial of forearm strengthening exercises in osteoarthritis of the small joints of the hand RCT (active) ACTRN12611000102976

Forearm strengthening exercises; usual pain medication (no exercise)

Primary OA of small joints of the hand

Active 66 Adt Sen

Mar-11 > Jun-11

Westmead Hospital, NSW, Australia

http://www.anzctr.org.au/trial_view.aspx?ID=336457

Hypoalgesic and motor effects of Kaltenborn mobilization on elderly patients with secondary thumb carpometacarpal osteoarthritis RCT (placebo) ISRCTN06361999

Kaltenborn mobilization of posterior-anterior gliding with distraction of the carpometacarpal joint; placebo

Carpo-metacarpal OA

Ongoing 29 Sen May-11 Jun-11 Azienda Sanitaria Locale (ASL) 3 (Italy)


Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis RCT (placebo) ISRCTN81771317

Radial nerve mobilization; placebo

Thumb carpo-metacarpal OA

Comp 60 Adt Sen

Sep-10 May-11 Azienda Sanitaria Locale (ASL) 3 (Italy)


7

Does thumb joint mobilization decrease hyperalgesia in elderly patients with secondary thumb carpometacarpal osteoarthritis? RCT (placebo) ISRCTN70578774

Mobilization of posterior-anterior gliding of the trapezio-metacarpal joint; sham

Thumb carpo-metacarpal OA

Comp 28 Sen Dec-09 Sep-10 Azienda Sanitaria Locale (ASL) 3 (Italy)


Device

Splinting to Treat Hand Osteoarthritis Phase II: Non-randomized, parallel assignment, efficacy study NCT01249391

Splinting Hand OA Rec 45 Adt Sen

Sep-10 Sep-11 Imperial College London; National Institute for Health Research, United Kingdom

http://ClinicalTrials.gov/show/NCT01249391

To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome Non-randomized, parallel assignment, efficacy study NCT01277003

Aculife Magnetic Wave Therapist; TENS

Carpal Tunnel Syndrome

Rec 30 Child Adt

Sem

Dec-10 Feb-11 China Medical University Hospital


Dietary supplements

A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects Phase II: RCT (active), bio-availability study NCT01321281

AquaCal; AquaPT OA Rec 36 Adt

F-only

Mar-11 Oct-11 University College Cork; Marigot Ltd.


Drugs including biologics

A multiple-center, randomized, double-blind, placebo-controlled, parallel-group comparison study in idiopathic carpal tunnel syndrome Phase II: RCT (placebo) JapicCTI-111500

OP-1206alpha-CD

Idiopathic carpal tunnel syndrome

Active 150 Adt Sen

Apr-11 Jul-12 Ono Pharmaceutical Co., Ltd. (japan)

via http://www.clinicaltrials.jp/user/ctiMain_e.jsp

8

An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with Dupuytren's contractures Single group assignment, safety and pharmokinetics study ACTRN12610001045000

AA4500 Dupuytren's contracture

? 12 Adt Sen

Dec-10 > Mar-11

Auxilium Phamaceuticals, Inc. (US); Novotech Pty Ltd (Australia)


A short course of low dose steroid tablets as a treatment for painful hand osteoarthritis- does it work? RCT (placebo) ISRCTN99697616

Prednisolone 5mg.day-1; placebo

Painful hand OA

Comp 70 Adt Sen

Aug-09 Dec-10 University of Leeds (UK)


Miscellaneous observational studies

Norwegian Very Early Arthritis Clinic (NOR-VEAC): spectrum of arthritides, disease course and predictors of outcomes Multicentre cohort study ISRCTN05526276

RA; un-differentiated arthritis

Ongoing 2000 Adt Sen

Aug-10 Jan-17 Diakonhjemmet Hospital (Norway)


A2: ELBOW PAIN

Title Phases: trial design (control) CT ID


Start Date

End Date

Sponsors URL

Behavioural, education & exercise including physiotherapy & manual therapy

Eccentric Training With or Without Elbow Brace for Epicondylitis Phase III: RCT (active), efficacy study NCT01273688

Eccentric training (Flex-Bar); EpiHit elbow brace

Epicondylitis; Tendinopathy; Pain

Not yet Rec

90 Adt Sen

Feb-11 Nov-11 Hannover Medical School


9

Device

VIBration Training in EpicondylitiS Phase III: RCT (active), efficacy study NCT01269879

Flexi-Bar vibration device only; Flexi-Bar + XCO-Trainer

Epicondylitis; Pain; Tendinopathy

Not yet Rec

70 Adt Jan-11 Sep-11 Hannover Medical School


A3: SHOULDER PAIN



Start Date

End Date

Sponsors URL


Subacromial impingement syndrome and pain: a randomised controlled trial of exercise and injection (the SUPPORT trial) RCT (active) ISRCTN42399123

Ultrasound-guided or unguided cortico-steroid injection, with either physiotherapist-led individualised, supervised & progressed exercise or an advice & exercise leaflet

Subacromial impingement syndrome

Active 252 Adt Sen

Mar-11 Sep-13 Keele University (UK)


Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement RCT (active), efficacy study NCT01257113

Supervised exercise; Home-based exercises

Shoulder Impingement Syndrome

Rec 46 Adt Jan-11 Dec-11 Norwegian University of Science and Technology


Effectiveness of Transverse Friction Massage in Latent Myofascial Trigger Points in Anterior Deltoid Muscle RCT (active), efficacy study NCT01275482

Transverse friction massage (TFM)

Myofascial Trigger Points; Myofascial Pain

Comp 40 Adt Sen

M-

only

Jan-11 Mar-11 University of Castilla-La Mancha


10

Progressive Resistance Training of the Biceps in Subacromial Impingement Syndrome RCT (active), efficacy study NCT01314196

Therapeutic exercises; Biceps resistance training and therapeutic exercises

Shoulder Impingement Syndrome

Comp 60 Adt Dec-08 Dec-10 Federal University of São Paulo


Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV RCT (active), efficacy study NCT01250184

Physical therapy; Blocking the MTP with lidocaine injection; Blocking the MTP plus physical therapy

Myofascial Pain Syndrome; Pain; Myofascial Trigger Point; Anesthetics, Local; Physical Therapy Modalities

Rec 150 Adt May-09 Nov-10 Grupo Rehabilitacion en Salud; Universidad de Antioquia



Does subacromial injection influence shoulder strength? RCT (placebo) ISRCTN50853594

Local anesthetic; Placebo

Shoulder pain; Active 10 Adt Apr-11 Apr-12 Balgrist University Hospital (Switzerland)


Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis Phase II: RCT (active), efficacy study NCT01306708

Amitriptyline Adhesive Capsulitis

Rec 34 Adt Sen

Feb-11 Jul-11 Universidade do Sul de Santa Catarina


"MILNACIPRAN" in Subjects With Chronic Shoulder Pain Phase IV: RCT (placebo), safety/efficacy study NCT01289236

Milnacipran; Placebo

Shoulder Pain Chronic

Active, NR

40 Adt Sen

Oct-09 Jun-11 Delray Research Associates; Forest Laboratories


Procedure

Accuracy of Needle Placement Into The Subacromial Space of The Shoulder RCT (active), efficacy study NCT01330641

Injection of Subacromial Bursa

Rotator Cuff Tendonitis

Comp 75 Adt Sen

Sep-08 Mar-11 University of California, Davis


11

Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV: RCT (active), efficacy study NCT01250184

Physical therapy; Blocking the MTP with lidocaine injection; Blocking the MTP plus physical therapy




Other including CAM therapies

Massage in Treating Painful Shoulder RCT (active) NCT01307826

Massage Shoulder Pain Syndrome; Pain; Frozen Shoulder

Comp N/K Adt Sen

Jan-08 Sep-10 University School of Physical Education in Wroclaw



Validation of a Score for Shoulder Function Evaluation Based on Movement Analysis Observational: Prospective cohort study NCT01281085

Shoulder Pain Comp 16 Adt Sen

Oct-10 Apr-11 Haute Ecole Cantonale Vaudoise de Santé; Réseau d'études appliquées des pratiques de Santé de Réadapation (ré)insertion


Burden of Shoulder Disorders in Primary Health Care Observational: Prospective cohort study NCT01300091

Shoulder Pain; Shoulder Mobility Impairment

Active, not Rec

128 ChildAdt Sen

Oct-07 Mar-11 Central Finland Hospital District; The Regional State Administrative Agency


Symptoms of Degeneration in Shoulder of Wheelchair-users Observational: Prospective cohort study NCT01263184

Degeneration; Shoulder Pain

Rec 60 Adt Nov-09 ? Nov-10

Hannover Medical School


12

Evaluation of the Difference in the Acromion Humerus Gap at Sitting,Lying Observational: Cross-sectional, case-only study NCT01264926

Shoulder Impingement Syndrome.

Not yet Rec

Adt Sen

? Dec-10

Hadassah Medical Organization


A4: NECK PAIN



Start Date

End Date

Sponsors URL


To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain Phase I: RCT (active), safety/efficacy study NCT01310595

Manual mobilization on cervical spine; Infra-red therapy with self exercise pamphlet

Neck Pain Rec 180 Adt Jan-10 Dec-13 The Hong Kong Polytechnic University


Assessing the effectiveness of a lateral glide cervical spine mobilisation on cervicobrachial (neck and arm) pain RCT (active) ISRCTN62431186

Self−management protocol with lateral glide mobilization; self−management protocol

Musculoskeletal pain; Neck and arm; cervicobrachial pain

Ongoing 96 Adt Jun-09 Jun-12 University of Birmingham (UK)


The effectiveness of physiotherapy on patients with dizziness and pain caused by a neck problem RCT (placebo) ACTRN12611000073909

Cervical Sustained Natural Apophyseal Glides; Passive joint mobilisation; Placebo

Dizziness and pain from cervical spine problems

Ongoing 90 Adt Sen

Apr-10 > Apr-12

University of Newcastle, NSW (Australia)


13

The effect of exercise program for prevention of musculoskeletal disorders in the neck, upper back and low back among office workers RCT ISRCTN16436892

Exercise program; normal activity

Non-specific neck, upper back and low back pain

Active 1004 Adt Jan-11 Mar-12 Social Security Office of Thailand (Thailand)


Effects of Sensomotoric Training on Neck/Scapular Pain in People With Visual Disability Phase IV: RCT (active), efficacy study NCT01361906

Sensomotoric training

Neck/Scapular Pain

Active, NR

52 Adt Sen

Sep-10 Feb-12 Centre for Rehabilitation Research, Örebro; Örebro County Council Centre for Musculoskeletal Research, University of Gävle


Exercise rehabilitation programs for chronic low back pain RCT (active) ACTRN12611000229976

Exercise rehabilitation program (pilates based); general exercise

Chronic non-specific low back pain

Active 52 Adt Apr-11 > Jun-11

University of Western Sydney (Australia)


Exploring the effectiveness of chiropractic care for spinal pain and measuring any side effects from that care. RCT (placebo), efficacy study ACTRN12611000542998

Usual Chiropractic Care; Sham

Non-specific spinal pain: pain associated with cervical, thoracic, or lumbar spine.

Ongoing 180 Adt Sen

Jun-11 >

Jun-11

Murdoch University (Australia)


Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials. RCT (active) UMIN000005332

Trigger point massage; non-trigger point massage; superficial massage

Low back pain; acute-subacute neck pain

Active 120 Child Adt

Apr-11 > Apr-11

University of Toyama (Japan)

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006336&language=E

Dose Optimisation for Spinal treatment Effectiveness (The DOSE Study): A randomised controlled pilot trial investigating the effects of high and low mobilisation forces in patients with neck pain RCT (placebo) ACTRN12611000374965

High force mobilisation; Low force mobilisation; Laser. Out of these three interventions, one will be placebo.

Chronic non-specific neck pain

Ongoing 66 Adt Apr-11 > Apr-11

The University of Newcastle, NSW (Australia)


14

Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine RCT (active), efficacy study NCT01318720

Manual Therapy Neck Pain Rec 64 Adt Nov-09 Apr-11 Masefield and Cavallaro Physical Therapy


Strain-counterstrain to treat restrictions of the mobility of the cervical spine - a randomized trial RCT (placebo) DRKS00000691

Strain-counterstrain (osteopathy); sham

Cervicalgia; limited cervical mobility and neck pain

Ongoing 60 Adt Feb-11 > Feb-11

Institut für Allgemeinmedizin Klinikum rechts der Isar der TU München

https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000691

A comparison of conventional physiotherapy to physiotherapy and behavioural treatment for patients with chronic neck pain RCT (active) ISRCTN27611394

Progressive neck exercise programme (PNEP) only; PNEP with interactive behavioural modification therapy

Chronic non-specific neck pain

Comp 56 Child Adt Sen

Mar-08 Feb-11 Pennine Acute Hospitals NHS Trust (UK)


Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV: RCT (active), efficacy study NCT01250184

Physical therapy; Blocking the MTP with lidocaine injection; blocking the MTP plus physical therapy




Patient-Oriented versus Prescription-Oriented rehabilitation in the management of chronic mechanical neck pain: a randomized controlled trial. RCT (active) ACTRN12611000107921

Patient-oriented rehabilitation (physical therapy responsive to patient needs); Prescription-oriented rehabilitation (physical therapy prescribed at referral and not adjusted)

Chronic mechanical neck pain

Comp 200 Adt Sen

Jun-10 > Aug-10

Sapienza University (Italy)


15


Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain Phase IV: RCT (placebo), safety/efficacy study NCT01335724

Diclofenac diethylamine 1.16% gel; Placebo gel

Neck Pain Rec 72 Adt Sen

Apr-11 Aug-11 Novartis http://ClinicalTrials.gov/show/NCT01335724

A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL Phase III: RCT (active) UMIN000004825

Lecoxib; Limaprost alfadex

Lumbar spine stenosis

134 Adt Sen

Jan-11 > Mar-11

University of Tsukuba (Japan)


Procedures

Dry Needling Versus Strain-counterstrain on the Upper Trapezius RCT (placebo), efficacy study NCT01290653

Dry needling; Strain-counterstrain technique; Placebo manual technique

Neck Pain Not yet rec

60 Adt Sen

Feb-11 Jul-11 Cardenal Herrera University


The use of a three dimensional ultrasound-based measurement device for the evaluation of subjects with and without neckpain Non-randomized, controlled diagnostic study DRKS00000794

3-D ultrasound-based device

Cervicalgia Ongoing 180 Adt Sen

Apr-10 > Apr-11

Philipps-Universität Marburg Fachbereich Medizin Physiotherapie


Development of evaluation and management for returning to work in workers on sick leave because of chronic low back pain Single group assignment UMIN000004472

Evaluation and management

Chronic low back pain

N/K 30 Adt Oct-10 > Oct-10

Kanto Rosai Hospital (Japan)


16

Efficacy of the novel comprehensive management program for low back pain in care workers Non-randomized, parallel assignment, efficacy study UMIN000004473

Novel comprehensive management program; Self-management with the evidence-based booklet.

Low back pain Invite 300 Adt Sen

Oct-10 > Oct-10

Kanto Rosai Hospital (Japan)



Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain RCT (active), efficacy study NCT01301170

Dry needling Neck Pain Rec 66 Adt Feb-11 Mar-12 Integrated Therapy Practice PC


Hatha yoga (Iyengar Yoga) for neck and cervical spine pain: a randomized controlled trial RCT (active), efficacy study DRKS00000454

Iyengar yoga; neck & cervical spine exercise

Cervicalgia Comp 56 Adt Feb-10 Aug-10 Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee


Effects of Thermotherapy on Chronic Neck Pain RCT, efficacy study NCT01304368

Thermotherapy Neck Pain Comp 50 Adt Sen

Aug-09 Aug-10 Universität Duisburg-Essen


The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain RCT (active), efficacy study NCT01289964

Dry Cupping or fire cupping

Neck Pain; Neck Pain Musculoskeletal; Mechanical/Motor Problems With Neck and Trunk

Comp 50 Adt Sen

Jul-09 Dec-09 Universität Duisburg-Essen


17

A5: BACK PAIN


Interventions Conditions

Recruit N Age Grp

Start Date

End Date

Sponsors URL


Yoga vs. Physical Therapy for Chronic Low Back Pain in Minority Populations Phase I: RCT (active), efficacy study NCT01343927

Yoga Class; Physical therapy; Education

Chronic Non-Specific Low Back Pain

Not yet rec

416 Adt May-11 Aug-15 Boston Medical Center


Mechanisms of Specific Trunk Exercises in Low Back Pain Phase I/II: RCT (active), efficacy study NCT01362049

Physical Therapy rehabilitation: Stabilization exercises.; Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise

Low Back Pain Rec 92 Adt Mar-10 Jul-13 University of Vermont; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Collaborative Care for Older Adults With Back Pain (COCOA) Phase II: RCT (active), efficacy study NCT01312233

Medical Care; Dual Care; Shared Care

Low Back Pain Rec 120 Adt Sen

Mar-11 Aug-12 Palmer College of Chiropractic; Health Resources and Services Administration; Genesis Family Medical Center; University of Iowa; Thomas Jefferson University


Online Cognitive Behavioral Therapy (CBT) Workbook Phase II: RCT (active), efficacy study NCT01337843

Wellness Workbook; Pain Management Print Materials

Low Back Pain Not yet rec

198 Adt Sen

Apr-11 Jul-12 Talaria, Inc; National Institute of Arthritis and Musculoskeletal and Skin Diseases


18

Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT, Health Services Research NCT01345123

Condition specific DVD & Pamphlet on Shared Decision Making plus Telephonic outreach & support by Health Coach; Telephonic outreach only; No intervention

Knee Pain Chronic; Arthritis (Hip); Arthritis (Knee); Back Pain

Rec 18000 Adt Sen

Feb-11 Mar-12 Health Dialog; Foundation for Informed Medical Decision Making; University of Massachusetts, Boston


The effect of exercise program for prevention of musculoskeletal disorders in the neck, upper back and low back among office workers RCT (active), efficacy study ISRCTN16436892

Exercise program; normal activity

Non-specific neck, upper back and low back pain

Active 1004 Adt Jan-11 Mar-12 Social Security Office of Thailand (Thailand)


Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT) RCT (active), efficacy study NCT01360359

Physical Therapy Exercise Program

Low Back Pain Rec 30 Adt May-11 Mar-12 Drexel University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Investigating a psychological intervention for people with long-term lower back pain Phase II: RCT (active) ISRCTN43733490

Contextual CBT; Physiotherapy-led treatment

Low Back Pain Active 92 Adt Sen

Jun-11 Feb-12 Royal Holloway, University of London (UK)


Yoga and Qigong for Elderly Patients With Chronic Low Back Pain Phase II/III: RCT (active), efficacy study NCT01303588

Yoga; Qigong; Waiting Group


180 Adt Sen

Feb-11 Dec-11 Charite University, Berlin, Germany


Acupuncture and manual therapy for low back pain RCT (active) ISRCTN05293321

Acupuncture; Manual therapy; Acupuncture & Manual therapy; Usual care

Low back pain Active 80 Adt Apr-11 Oct-11 University of York (UK)


19

Can motor performance of chronic low back pain patients be improved via motivating feedback by means of gaming? RCT (crossover) NTR2785

Provoking position whilst gaming; Neutral position whilst gaming.

Chronic Low back pain

Active 45 Adt Sen

Jul-10 Jul-11 Roessingh Research and Development b.v. (The Netherlands)

http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2785

Exploring the effectiveness of chiropractic care for spinal pain and measuring any side effects from that care. RCT (placebo), efficacy study ACTRN12611000542998

Usual Chiropractic Care; Sham

Non-specific spinal pain: pain associated with cervical, thoracic, or lumbar spine.

Ongoing 180 Adt Sen

Jun-11 > Jun-11

Murdoch University (Australia)


Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain RCT (active), efficacy study NCT01314157

Isostretching Chronic Low Back Pain

Not yet rec

54 Adt Mar-11 Jun-11 Federal University of São Paulo


Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials. RCT (active) UMIN000005332

Trigger point massage; non-trigger point massage; superficial massage

Low back pain; acute-subacute neck pain

Active 120 Child Adt

Apr-11 > Apr-11

University of Toyama (Japan)


Development and evaluation of a patient education intervention to improve health literacy (HL) for patients with chronic illness Non-randomized controlled trial (historical) DRKS00000655

Health education intervention; no health education.

Chronic back pain; arthrosis

Active 500 Adt Sen

Apr-11 > Apr-11

Universitätaklinikum Freiburg Abteilung für Qualitätsmanagement und Sozialmedizin (Germany)


Evaluation of the effectiveness of a consumer pamphlet for low back pain RCT (active), efficacy study ACTRN12611000053921

Pamphlet only; Pamphlet & education; No pamplet

Low Back Pain Active 360 Adt Sen

Feb-11 > Apr-11

Curtin University (Australia); Musculoskeletal Health Network (Australia)


20

Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study Observational: Cross-sectional, case-only study NCT01258543

General Osteopathic Evaluation

Inter-examiner Reliability; Location and Nature of Restriction or Lesion; Non-specific Back Pain

Rec 20 Adt Nov-10 Jan-11 Kirnan, Jaime http://ClinicalTrials.gov/show/NCT01258543

Massage for Low Back Pain in Nursing Staff Single group assignment, efficacy study NCT01315197

Massage Low Back Pain Comp 18 Adt Oct-10 Dec-10 University of Sao Paulo


Effectiveness of Fascial Manipulation for Chronic Low Back Pain RCT (active), efficacy study NCT01269983

Fascial Manipulation

Low Back Pain Rec 50 Adt Apr-09 Dec-10 University of Bologna


Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients RCT (active), efficacy study NCT01342432

General exercise only; Balance reeducation plus general exercise

Low Back Pain Comp 35 Adt Sen

Jan-09 Oct-09 Centro Universitari Fieo; University of Sao Paulo


Device

Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine Single group assignment, safety/efficacy study NCT01323543

Elaspine™ Lower Back Pain Rec 40 Adt Sen

Aug-10 Dec-20 Spinelab AG; MDT Medical Device Testing GmbH


Study of Barricaid Device Phase IV: RCT (active) NCT01283438

Barricaid; Standard of Care

Lumbar Disc Herniation

Rec 400 Adt Sen

Dec-10 May-14 Intrinsic Therapeutics


21

Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain Phase IV: RCT (active), safety/efficacy study NCT01263054

TransDiscal System; Medical Management

Back Pain Rec 136 Adt Sen

Dec-10 May-13 Kimberly-Clark Corporation


Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs Phase I: Single group assignment, safety/efficacy study NCT01339377

AO-1000 Disk, Herniated Not yet rec

40 Adt Sen

May-11 Jul-12 ActiveO Inc. http://ClinicalTrials.gov/show/NCT01339377

Senza™ spinal cord stimulation system for the treatment of chronic back and leg pain in failed back surgery syndrome (FBSS) patients RCT (placebo) ISRCTN33292457

Permanent spinal cord stimulation implant

Chronic back and leg pain in failed back surgery syndrome (FBSS) patients

Active 20 Adt Sen

Apr-11 Apr-12 Nevro Corporation (USA)


Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment RCT (placebo) ISRCTN08714168

Automatic thermomechanic massage system (SMATH System); Sham

Subacute and chronic Low Back Pain

Active 72 Adt Jan-11 Jan-12 Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)


Comparative Study of Static and Dynamic Back Supports for Lower Back Pain Non-randomized, parallel group assignment, efficacy study NCT01269619

Dynamic back support; Static back support

Low Back Pain, Mechanical

Not yet rec

20 Adt Feb-11 Apr-11 Wolfson Medical Center


Pilot study on the effect of Intradiscal Pulsed RadioFrequency treatment for the management of low back pain and ischialgia of discogenic origin Prospective longitudinal observational trial ISRCTN46778702

Intradiscal Pulsed RadioFrequency treatment

Discogenic low back pain

Comp 50 Adt Sen

Mar-08 Feb-11 Orbis Medical Centre Sittard-Geleen (Netherlands)


22

The role of leg length discrepancy in low back pain RCT (placebo) ISRCTN11898558

Corrective soles; Soles without correction

Low Back Pain Comp 42 Adt Sen

Feb-09 Feb-10 South Ostrobothnia Central Hospital (Finland)


The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders Single group assignment, efficacy study NCT01266382

AposTherapy OA; Spinal Diseases; Ligament Rupture; Lower Extremity Fracture; Neurological Disorders

Rec Adt Sen

N/K ? Jul-09

Assaf-Harofeh Medical Center; Apos Medical and Sports Technology LTD.


Dietary supplements



F-only




Lumbar Infiltration With Steroids - Effects on Pain Reduction Observational: Prospective, case-only study NCT01330875

Steroids Low Back Pain Rec 100 Adt Sen

Dec-10 Jan-15 University of Zurich http://ClinicalTrials.gov/show/NCT01330875

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain Phase III: Single group assignment, safety/efficacy study NCT01298765

BEMA Buprenorphine

Pain; Low Back Pain; OA; Neuralgia

Rec 300 Adt Sen

Mar-11 Sep-12 BioDelivery Sciences International


23

Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain Phase III: RCT (placebo), safety/efficacy study NCT01358526

Oxycodone/ Naloxone controlled-release; Placebo


May-11 Aug-12 Purdue Pharma LP http://ClinicalTrials.gov/show/NCT01358526

Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study Phase IV: Single group assignment, safety/efficacy study NCT01298466

Pregabalin Low Back Pain; Neuralgia

Not yet rec

600 Adt Sen

Sep-11 Jun-12 Pfizer http://ClinicalTrials.gov/show/NCT01298466

The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP) Phase II: RCT (placebo), efficacy Study NCT01330238

Zoledronic acid; placebo


Dec-08 Mar-12 University of Oulu; Novartis Pharmaceuticals


Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin Phase IV: RCT (active), efficacy study NCT01352741

Tapentadol PR; Tapentadol PR with Pregabalin; Tapentadol PR open label maintenance

Low Back Pain; Neuropathic Pain

Rec 500 Adt Sen

Mar-11 Jan-12 Grünenthal GmbH http://ClinicalTrials.gov/show/NCT01352741

A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain Phase III: RCT (active), safety/efficacy study NCT01300312

Eperisone hydrochloride & Diclofenac sodium; Eperisone hydrochloride

Acute Musculoskeletal Spasm Due to Low Back Pain

Rec 240 Adt Feb-11 Nov-11 Eisai Co., Ltd. http://ClinicalTrials.gov/show/NCT01300312

24

Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain Phase IV: RCT (active), safety/efficacy study NCT01344720

Etoricoxib; Oxycodone


250 Adt Sen

May-11 Jun-11 Azienda Sanitaria Locale 4, Teramo


Efficacy and Safety Study of BEMA Buprenorphine in Subjects With Low Back Pain Phase III: RCT (placebo), safety/efficacy study NCT01256450

BEMA Buprenorphine; BEMA Placebo

Pain; Low Back Pain

Active, NR

300 Adt Sen

Dec-10 Jun-11 BioDelivery Sciences International



Integrated Chiropractic and Acupuncture Treatment for Low Back Pain Phase II: RCT (active), efficacy study NCT01357343

Chiropractic; Acupuncture


Feb-11 Aug-13 Southern California University of Health Sciences


The influence of a non-invasive electrical stimulation over an area of the brain on pain and disability in patients with long-standing back pain RCT (placebo), efficacy study ISRCTN89874874

Anodal transcranial direct current stimulation; sham


Ongoing 135 Adt Feb-11 Aug-11 University Medical Center Hamburg-Eppendorf (Germany)


Motion Style Treatment (MST) Acupuncture for Low Back Pain With Severe Disability RCT (active), efficacy study NCT01315561

Acupuncture, injection

Complete Immobility Due to Severe Physical Disability

Rec 58 Adt Apr-11 Aug-11 Jaseng Hospital of Oriental Medicine


Cryoneurolysis versus steroid infiltration for treatment of lumbar facet joint syndrome: a randomized controlled double-blind study RCT (active) DRKS00000659

Cryoneurolysis; steroid infiltration


N/K 30 Adt Sen

Jan-11 > Jan-11

Interdisziplinäres Schmerzzentrum Universitätsklinikum Freiburg (Germany)


25

Procedures

Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Chronic Discogenic Lumbar Back Pain Phase II: RCT (placebo), safety/efficacy study NCT01290367

MPCs Injection; Saline injection

Degenerative Disc Disease

Not yet rec

80 Adt Sen

May-11 May-15 Mesoblast, Ltd. http://ClinicalTrials.gov/show/NCT01290367

Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial Phase III: RCT (active), efficacy study NCT01335646

Lumbar Microdiscectomy; Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories

Lumbar Spine Disc Herniation; Lumbar Radiculopathy

Rec 140 Adt Feb-10 Mar-15 The London Spine Centre; The Physicians' Services Incorporated Foundation; Lawson Health Research Institute


Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position Observational: Prospective, case control study NCT01323127

Sagital X-rays Back Pain; Low Back Pain

Not yet rec

20 Adt Sen

May-11 Dec-11 Centre Hospitalier Universitaire de Nīmes


Structural Integration for Chronic Low Back Pain RCT (active), efficacy study NCT01322399

Structural Integration; Usual care

Back Pain Lower Back Chronic

Rec 40 Adt Dec-10 Oct-11 Spaulding Rehabilitation Hospital; National Center for Complementary and Alternative Medicine (NCCAM)


An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique RCT (active), safety/efficacy study NCT01300715

Lumbar medial branch radiofrequency neurotomy

Low Back Pain; Lumbar Facet Joint Pain; Arthropathy

Rec 100 Adt Sen

Nov-10 May-11 Seoul National University Bundang Hospital


26


Observational Cohort Study of Chronic Low Back Pain Observational: Prospective cohort study NCT01355237

Back Pain Lower Back Chronic

Not yet rec

300 Adt Sen

Jun-11 Jun-15 Brigham and Women's Hospital; Harvard University; Beth Israel Deaconess Medical Center


Pain Quality Study Observational: Cross-sectional, case-only study NCT01321190

Low Back Pain; Headache; Fibromyalgia

Not yet rec

300 Adt Sen

Jun-11 Mar-13 University of Washington; Merck


Maverick Total Disc Replacement in a 'Real World' Patient Population Observational: Prospective, case-only study NCT01338493

Degenerative Disc Disease

Active, NR

150 Child Adt Sen

Feb-09 Feb-13 Medtronic Spinal & Biologics ECA


A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain Observational: Prospective cohort study NCT01293994

Pain; Chronic low back pain

Invite 500 Adt Sen

Feb-09 Dec-12 Stanford University http://ClinicalTrials.gov/show/NCT01293994

ATLAS – Assessment and Treatment of Leg pain Associated with the Spine Observational: Cohort Study UKCRN 9961

Low back pain and radiating leg pain

Active 500 Adt Sen

N/K Nov-12 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9961

Adjacent Segment Disc Degeneration (ASDD) Multicentre Observational: Cohort study UKCRN 9656

Fusion and non-operative care

Chronic low back pain;

Active 600 N/K N/K May-12 Nuffield Orthopaedic Centre NHS Trust

http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9656

Patients’ treatment beliefs in back pain UKCRN 9683

Persistent non-specific low back pain

Active 380 N/K N/K Jan-12 University of Southampton


JOBA® & Chronic LOw BAck Pain Observational: Case Control NCT01259167

Low Back Pain; Invite 50 Adt Sen

Jan-11 Jun-11 Catholic University of the Sacred Heart


27

Clinicians' treatment beliefs in back pain Qualitative study UKCRN 9490

Persistent Non-Specific Low Back Pa

Active 40 Adt N/K Jun-11 University of Southampton


Validity of the Fingertip-to-floor test DRKS00003075

Dorsopathies Comp 55 Adt Mar-11 May-11 Philipps-Universität Marburg, Fachbereich Medizin, Studiengang Physiotherapie Master (Germany)


Patient-oriented outcome measurement: Health valuations and the assessment of the participation relevance of treatment effects by chronically ill patients (POEM) DRKS00000744

Chronic back pain; Spondylosis; Spondylopathies; Collapsed vertebra; intervertebral disc disorders; dorsopathies; Dorsalgia; Persistent somatoform pain disorder

Comp 600 Adt Sen

Apr-08 Feb-11 Universitätsklinikum Freiburg Abteilung Qualitätsmanagement und Sozialmedizin (Germany)


28

A6: HIP PAIN



Start Date

End Date

Sponsors URL


Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT (active), health services research NCT01345123



Rec 18000 Adt Sen



A7: KNEE PAIN



Start Date

End Date

Sponsors URL


Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT (active), health services research NCT01345123



Rec 18000 Adt Sen



29

Exercise and Pain Sensitivity RCT (active) NCT01351558

Knee muscle strengthening exercises; Upper extremity strengthening exercises; Cardiovascular fitness exercises

Knee Pain Rec 120 Adt May-11 Mar-12 Frederiksberg University Hospital


The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain RCT (active) NCT01346995

Experimental knee pain; Non-painful control injections

Muscle Strength Comp 36 Adt Feb-10 Aug-10 Frederiksberg University Hospital


Dietary supplement

Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort RCT (active), safety/efficacy study NCT01303432

Yogurt supplemented with Mobilee; Yogurt

Low Intensity Knee Gonalgia

Active, NR

80 Adt Sen

Sep-10 Mar-11 Bioiberica; Technological Centre of Nutrition and Health


Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain Phase IV: RCT (placebo), efficacy study NCT01351805

Fish Oil; Vitamin D; placebo pill

Autoimmune Diseases; Systemic Inflammation; Knee Pain; OA; RA

Rec 20000

Adt Sen

Jan-11 Dec-16 Brigham and Women's Hospital; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Device

The use of in-shoe foot orthoses in the short-term treatment of anterior knee pain RCT, efficacy study ACTRN12611000492954

Prefabricated, full length in-shoe orthoses; wait and see

Anterior knee pain

Comp 40 Adt Sep-09 > Oct-09

University of Queensland;

Australian Institute of Sport


30

The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders NCT01266382

AposTherapy OA; Spinal Diseases; Ligament Rupture; Lower Extremity Fracture; Neurological Disorders

Rec Adt Sen

N/K ? Jul-09

Assaf-Harofeh Medical Center;

Apos Medical and Sports

Technology LTD.


A8: FOOT, ANKLE & TOE PAIN

Title Phases: study designs (control) CT ID


Start Date

End Date

Sponsors URL


A Study on Exercise After Achilles Tendon Rupture Phase II: RCT (active), safety/efficacy study NCT01298024

Early Neuromuscular Exercise

Achilles Tendon Rupture

Rec 30 Adt Mar-11 Oct-12 Region Skane; Lund University


Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis Phase II/III: RCT (crossover), efficacy study NCT01297686

Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training; Gastrocnemius & soleus stretching and Dexamethasone

Fasciitis, Plantar

Not yet rec

100 Adt May-11 Apr-12 University of British Columbia


31

Device

Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions Phase III: RCT (active), safety/efficacy study NCT01305356

Augment(tm) Injectable Bone Graft; Autologous bone graft

Degenerative Joint Disease; Congenital Deformity; Arthritis; OA; RA

Rec 201 Adt Sen

Mar-11 Mar-14 BioMimetic Therapeutics


Footwear Minimalism Study Phase II: RCT (active), efficacy study NCT01334346

Nike Pegasus; Nike Free 3.0; Vibram Five Fingers Shoe

Healthy Runners

Not yet rec

144 Adt Jul-11 Jul-12 University of British Columbia; Nike Inc.


Orthotics in the treatment of plantar fasciitis. A prospective randomized trial to compare three different biomechanical concepts of orthotics. RCT (active), efficacy study DRKS00000742

Thin, prefabricated, over the counter insert; foam insert (classic treatment); heel insert with thin self-supporting plastic core, central plantar heel recess & plantar fanning.

Plantar fasciitis Comp 30 Adt Sen

Mar-09 Jul-10 Zentrum für Fuß- und Sprunggelenkchirurgie Schön Klinik München Harlaching (Germany)


Dietary supplements



F-only



32

Drugs including biological

A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine) RCT (placebo), pharmacodynamics study NCT01298310

Xylocaine; Placebo Morton's Metatarsalgia

Rec 30 Adt Sen

Feb-11 Jun-11 AstraZeneca http://ClinicalTrials.gov/show/NCT01298310

NRD101 Phase II Dose finding study on plantar fasciitis patients Phase II: RCT (placebo) JapicCTI-101090

Sodium Hyaluronate; Placebo

Plantar fasciitis Comp 150 Adt Sen

Apr-10 Jun-11 Chugai Pharmaceutical Co., Ltd.

Via http://www.clinicaltrials.jp/user/cte_main_e.jsp


Prolotherapy for the Treatment of Plantar Fasciitis Phase IV: RCT (active), efficacy study NCT01326351

Regenerative injection therapy; Dry needle injection; Exercise

Plantar Fasciitis

Not yet rec

60 Adt Sen

May-11 Feb-12 Réseau de Santé Vitalité Health Network


33

A9: FIBROMYALGIA



Start Date

End Date

Sponsors URL


Qigong Exercise May Benefit Patients With Fibromyalgia RCT (placebo, crossover), efficacy study NCT01333566

Qigong Fibromyalgia Rec 80 Adt Sen

Jul-09 Jul-12 University of Kansas


The Functional Neuroanatomy of Catastrophizing: an fMRI Study RCT (active) NCT01345344

CBT; Education Fibromyalgia Rec 60 Adt Sen

Aug-10 Dec-11 Brigham and Women's Hospital; Massachusetts General Hospital; Arthritis Foundation


Fibromyalgia pain reproduction by manual stimulation of active myofascial trigger points as compared to latent myofascial trigger points in health controls in pain intensity and pain area RCT (active) ISRCTN43167547

Active stimulation of myofascial trigger points; latent myofascial trigger points.

Fibromyalgia Comp 60 Adt Sen

Jan-09 Dec-10 The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA)


Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment Phase II: RCT (active), efficacy study NCT01266733

Interdisciplinary treatment of fibromyalgia; Usual treatment

Fibromyalgia Comp 153 Adt Sen

Feb-07 Feb-10 Hospital Galdakao-Usansolo


Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions RCT (active) NCT01278641

Graded strength resistance training program; Temperate pool exercise program

Fibromyalgia; Pain

Comp 44 Adt

M-only

Jan-08 Nov-09 Göteborg University


34

Device

Repetitive Transcranial Magnetic Stimulation in Fibromyalgia RCT (active), efficacy study NCT01308801

Active rTMS + rehabilitation exercise; placebo rTMS+ rehabilitation exercise

Fibromyalgia Not yet rec

60 Adt Sen

Apr-11 Nov-13 University Hospital, Grenoble; APICIL foundation


Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia RCT (crossover), safety/efficacy study NCT01298609

Occipital Nerve Stimulation

Fibromyalgia Rec 40 Adt Sen

Jun-10 Mar-12 St. Jude Medical http://ClinicalTrials.gov/show/NCT01298609

Evaluation of Magnetic Fields to Treat Fibromyalgia Phase II: RCT (active), efficacy study NCT01262131

Resonator Fibromyalgia Comp 30 Adt Sen

Dec-10 May-11 pico-tesla Magnetic Therapies, LLC


Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome Phase IV: RCT (placebo), efficacy study NCT01261650

Transcranial direct current stimulation; sham treatment


Dec-10 ? Dec-10

Karl Landsteiner Institute of Remobilization and Functional Health


Dietary supplements

The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms Phase II: RCT (placebo), efficacy study NCT01352013

Omega-3 oil; Fatty Acids (placebo)


40 Adt

F-only

Jun-11 Dec-12 McGill University Health Center; Alan Edwards Centre for Research on Pain


D-Ribose for Fatigue in Subjects With Fibromyalgia Phase II: RCT (placebo), safety/efficacy study NCT01315210

D-Ribose Powder; Placebo


100 Adt Sen

May-11 Jul-12 Bioenergy, Inc. http://ClinicalTrials.gov/show/NCT01315210

35


Combination drug therapy for fibromyalgia pain RCT (placebo), efficacy study ISRCTN20173707

Duloxetine & Pregabalin; Duloxetine; Pregabalin

Fibromyalgia Active 69 Adt Sen

Feb-11 Jan-14 Queen's University (Canada)


The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients Phase IV: RCT (placebo), efficacy study NCT01359826


Systemic Lupus Erythematosus; Widespread Pain; Fibromyalgia

Not yet rec

50 Adt Sen

Jun-11 Nov-13 Loma Linda University; Forest Laboratories


Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? RCT (active), efficacy study NCT01268631

Duloxetine; Pregabalin


150 Adt Sen

Jan-11 Jan-13 Tel-Aviv Sourasky Medical Center; University of California, Davis; Rambam Health Care Campus


Effect of Milnacipran on Pain in Fibromyalgia Phase IV: Single group assignment, efficacy study NCT01288807

Milnacipram Fibromyalgia Not yet rec

10 Adt Sen

F-only

Feb-11 Dec-12 University of California, San Diego; Forest Laboratories; Department of Veterans Affairs


Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients Phase II/III: RCT (placebo), safety/efficacy study NCT01271933

Pregabalin; placebo


Mar-11 May-12 Pfizer http://ClinicalTrials.gov/show/NCT01271933

Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients RCT (placebo), efficacy study NCT01294059

Milnacipran Fibromyalgia Rec 50 Adt Nov-09 Mar-12 University of Florida; Forest Laboratories


36

Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia Phase II: RCT (placebo), efficacy study NCT01323374

Droxidopa; Carbidopa; Droxidopa/ carbidopa; Placebo


Jan-09 Dec-11 Chelsea Therapeutics


Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study Phase IV: Observational, Prospective cohort study NCT01280747

Fibromyalgia; Painful Diabetic Peripheral Neuropathy

Active, NR

2288 Adt Sen

Jan-11 Dec-11 Pfizer http://ClinicalTrials.gov/show/NCT01280747

A double-blind, placebo-controlled phase II study of Org 3770 (mirtazapine) in patients with fibromyalgia Phase II: RCT (placebo) JapicCTI-101176

Mirtazapine (Org 3770); placebo

Fibromyalgia Active 120 Adt Jun-10 Jun-11 Meiji Seika Kaisha, Ltd (Japan)

Via http://www.clinicaltrials.jp/user/cte_main_e.jsp


Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain RCT (active), efficacy study NCT01352052

Interdisciplinary rehabilitation; Wait list control

Chronic Widespread Pain; Fibromyalgia

Invite 176 Adt Sen

F-only

May-11 Oct-12 Frederiksberg University Hospital; Oak Foundation


Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial Phase II: RCT (active), efficacy study NCT01291043

Shiatsu Fibromyalgia Active, NR

34 Adt Jul-10 Dec-11 University of Sao Paulo General Hospital



Pain Quality Study Observational: Cross-sectional, case-only study NCT01321190

Low Back Pain; Headache; Fibromyalgia

Not yet rec

300 Adt Sen

Jun-11 Mar-13 University of Washington; Merck


37

Understanding Day to Day Experiences, Activity and Mood UKCRN9707

Bipolar Disorder; Fibromyalgia, High HPS Scorers

Active 200 Adt Sen

N/K Nov-12 Lancaster University


Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia Observational: Prospective, case control study NCT01322425

Fibromyalgia; Pain

Rec 25 Adt

F-only

Jul-10 Dec-11 University of Minnesota - Clinical and Translational Science Institute


Is a good mood linked to a good nights sleep? UKCRN9706

Fibromyalgia; Bipolar Disorder

Active 700 Adt Sen

N/K Nov-11 Lancaster University


An Assessment of the Health Economic Impact of Fibromyalgia UKCRN 10240

Fibromyalgia Active 90 Adt Sen

N/K Oct-11 Poole Hospital NHS Foundation Trust


The Pathogenesis of Idiopathic Dry Eyes Observational: Cross-sectional, case control study NCT01254201

Dry Eye; Fibromyalgia

Comp 84 Adt Sen

F-only

Jun-08 Sep-10 University of Michigan


Epidemiology of Fibromyalgia in Japan UMIN000003550

Fibromyalgia Comp 300,000 Child Adt Sen

Apr-10 ? May-11

Tokyo-Eki Center-building Clinic (Japan)


38

A10: CHRONIC PAIN



Start Date

End Date

Sponsors URL


Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans Phase II: RCT (active), efficacy study NCT01350492

Resistance Exercise Training

Chronic Musculoskeletal Pain

Not yet rec

68 Adt Sep-11 Aug-16 Department of Veterans Affairs


Engaging older people and their careres to develop and deliver interventions for self management of chronic pain (EPIC) Observational: cohort study UKCRN 9346

All conditions; chronic pain

Active 2800 Sen N/K Aug-14 University of Aberdeen


Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain RCT (active), efficacy study NCT01346423

Interdisciplinary intervention; Brief Intervention

Musculoskeletal Pain

Rec 300 Adt Mar-11 Jan-14 Sykehuset Innlandet HF; University of Bergen


Returning to Work. Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" in Sicklisted Citizens With Chronic Musculoskeletal Pain Phase I/II: RCT (active), efficacy study NCT01356784

Tailored Physical Activity; “Chronic Pain Self-management Programme"; Health counselling


Rec 225 Adt Sen

May-11 Jul-13 University of Southern Denmark; DK-Sønderborg Municipality


Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities on musculoskeletal pain and physical activity in middle- and old- aged people: a cluster RCT Non-randomized, parallel assignment, efficacy study UMIN000002683

Community-wide campaign; as usual

Physical inactivity and musculoskeletal pain

Active NR

3000 Adt Sen

Oct-09 Feb-13 Physical Education and Medicine Research Center UNNAN; Tokyo Medical University


39

Improving the self management of chronic pain Pragmatic RCT (active) ISRCTN24426731

Self-management chronic pain course; usual GP care

Chronic musculoskeletal pain

Ongoing 700 Adt Sen

Jun-11 Jan-13 Queen Mary University of London (UK)


Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients RCT (active), efficacy study NCT01306747

The Stanford Chronic Pain Self-Management Programme

Chronic Pain Rec 500 Adt Sen

Feb-11 Jan-13 University of Aarhus; TRYG Foundation; The Danish Committee for Health Education


PREPARE- (Cost-) effectiveness of a pre-pain rehabilitation treatment, a Motivational interviewing (MI)-based nurse-led intervention in chronic non-specific musculoskeletal pain patients: A randomized controlled trial (RCT). RCT (active), efficacy study NTR2841

Motivational interviewing (MI)-based nurse-led intervention; PIL control condition

Chronic non-specific musculoskeletal pain

Ongoing 200 Adt Jun-11 Dec-12 University Maastricht (UM)


Reducing Long-Term Disability Related to Pain: Evaluation of the Pain Disability Prevention Program in the Irish health service RCT (active) ISRCTN61650533

Community based rehabilitation programme for chronic pain; Medical treatment as usual

Chronic Pain Ongoing 210 Adt Sen

Jan-11 Dec-12 National University of Ireland, Galway (NUIG) (Ireland)


Acceptance-Based Behavioural Therapy (ABBT) in chronic pain. Pilot study: Single group assignment NTR2868

Acceptance-Based Behavioural Therapy

Chronic Musculoskeletal Pain

Active 8 Adt May-11 May-12 Roessingh Research and Development b.v.


Device

A novel neuromodulation technique in the treatment of chronic pain. Single group assignment, efficacy study NTR2825

Neuromodulation Chronic neuropathic pain

Active 30 Adt Sen

Mar-11 Sep-12 Spinal Modulation, Inc.


40

Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters RCT (placebo), efficacy study NCT01261468

Active SCS; Deactivated


Jan-11 Jul-11 Danish Pain Research Center



Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis Phase IV: RCT (placebo), efficacy study NCT01329406


OA Not yet rec

50 Adt Sen

Apr-11 Sep-12 Analgesic Solutions; Forest Laboratories


Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain Phase III: Single group assignment, safety/efficacy study NCT01298765

BEMA Buprenorphine

Pain; Low Back Pain; OA; Neuralgia

Rec 300 Adt Sen

Mar-11 Sep-12 BioDelivery Sciences International


Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids RCT (placebo), safety/efficacy study NCT01304342

Remifentanil; Fentanyl; Normal saline


Feb-11 May-12 University of Athens


Long-term study of HFT-290 in patients with chronic pain. Phase III: uncontrolled trial JapicCTI-101348

HFT-290 (fentanyl citrate patch)

Chronic Pain ? N/K N/K Nov-10 > Nov-10

Hisamitsu Pharmaceutical Co., Inc.

via http://www.clinicaltrials.jp/user/cteSearch_e.jsp


Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes Observational: Retrospective cohort study NCT01346202

Chronic Pain Rec 260 Adt Jan-11 Mar-12 Klinikum St. Georg gGmbH


41

Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan Observational: Prospective cohort study NCT01345409

Chronic Pain Invite 1320 Adt Sen

Dec-10 Aug-15 Kaiser Permanente; University of Arizona; Oregon Health and Science University


The Healing Context in Complementary and Alternative Medicine (CAM): Instrument Development and Initial Validation Observational: Cross-sectional, ecologic or community study NCT01266304

Community Members Regardless of Medical Conditions.

Rec 72 Adt Sen

Jan-11 Aug-15 University of Pittsburgh


A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain Observational: Prospective cohort study NCT01293994

Pain Invite 500 Adt Sen

Feb-09 Dec-12 Stanford University


A11: PAIN

Title Phases: study design (control) NCT ID


Start Date

End Date

Sponsors URL

Behavioural, education & exercise incl. physiotherapy & manual therapy Neurofeedback and Pain Observational: Prospective cohort study NCT01278225

EEG biofeedback; Wait-List

Pain; Peripheral Neuropathy

Rec 72 Adt Sen

Feb-11 Mar-14 M.D. Anderson Cancer Center


Soccer and Zumba as health promoting activities among Norwegian hospital employees Cluster RCT ISRCTN61986892

Soccer; Zumba General health condition, including musculoskeletal pain

Ongoing 115 Adt Jan-11 Dec-11 Nordland Hospital Bodø (Norway)


42

Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain RCT (active), efficacy study NCT01346423

Interdisciplinary intervention; Brief Intervention


Rec 300 Adt Mar-11 Jan-14 Sykehuset Innlandet HF; University of Bergen


Device A Prospective Clinical Outcomes Registry Observational: prospective NCT01305525

St. Jude Medical Spinal Cord Stimulation Systems

Pain Rec 600 Adt Sen

Jun-09 ? May-11

Advanced Neuromodulation Systems


Tolerability Study of the Application of a 3M Microstructure Transdermal System Phase I: RCT (placebo), safety study NCT01257763

Transdermal Microchannel Skin System; Sham device

Healthy Comp 54 Adt Sen

May-10 Apr-11 Northwestern University; 3M


Dietary Supplements Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache Phase IV: RCT (placebo), efficacy study NCT01263288

Cholecalciferol; Placebo

Vitamin Deficiency

Rec 300 Adt Jan-11 Jan-13 University of Oslo; Norwegian School of Sport Sciences; Norwegian Institute of Public Health



AquaCal; AquaPT OA Rec 36 Adt F-

only



Drugs including biologics Non-cancer Pain and Cognitive Impairment: A Disabling Relationship RCT (active), safety/efficacy study NCT01264965

Long acting oxycodone; Extra strength acetaminophen

Arthritis; Pain; Cognitive Impairment

Not yet rec

155 Adt Sen

Jan-11 Aug-13 University of Chicago


43

Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis Phase III: RCT (active), safety/efficacy study NCT01293305

Chondroitin sulfate + Glucosamine sulfate; Chondroitin sulfate + Glucosamine sulphate

OA Not yet rec

320 Adt Sen

Nov-11 Dec-12 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.


Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen Phase IV: Single group assignment, safety/efficacy study NCT01334944

Intravenous ibuprofen

Pain; Fever Active, NR

150 Adt Sen

Apr-11 Jun-12 Cumberland Pharmaceuticals


Conversion From Fast Acting Oral Opioids to Abstral® Phase IV: Single group assignment, efficacy study NCT01315886

SL Fentanyl Pain Rec 71 Adt Sen

Feb-11 Feb-12 Orexo AB http://ClinicalTrials.gov/show/NCT01315886

Hyaluronan in the Treatment of Painful Tendinopathy Single group assignment, safety/efficacy study NCT01290510

Hyaluronic acid sodium salt

Tendinopathy Rec 80 Adt Sen

Feb-11 Dec-11 TRB Chemedica AG


Study of CG100649 Versus Celecoxib in Osteoarthritis Patients Phase II: RCT (active), safety/efficacy study NCT01341405

CG100649; Celecoxib

OA Rec 132 Adt Sen

Apr-11 Nov-11 CrystalGenomics, Inc.


Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine RCT (active), pharmacokinetics study NCT01296334

Morphine; Buprenorphine; saline

Pain Active, NR

34 Adt Feb-11 Oct-11 University of Copenhagen; Norpharma A/S


Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise Phase I: RCT (placebo) NCT01271348

Etoricoxib; placebo Muscle Pain Rec 50 Adt Sen

Jan-11 Oct-11 X-pert Med GmbH http://ClinicalTrials.gov/show/NCT01271348

44

A Safety and Efficacy Study of Oral Tapentadol Extended-release in Japanese Patients Phase III: RCT (active), safety/efficacy study NCT01309386

Morphine SR; Tapentadol

Pain; Analgesics; Neoplasms

Rec 100 Adt Sen

Aug-10 Jul-11 Janssen Pharmaceutical K.K.


Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain Phase II: RCT (placebo), safety/efficacy study NCT01307020

Dexketoprofen Trometamol; Tramadol Hydrochloride; Ibuprofen; Placebo

Pain Rec 600 Adt Sen

Feb-11 Jun-11 Menarini Group; PRA International


A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments Phase I: RCT (active), bio-equivalence study NCT01316978

Ibuprofen Pain Comp 30 Adt Feb-11 Mar-11 Johnson & Johnson Consumer & Personal Products Worldwide


A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers. Phase I: RCT (active), safety study NCT01259882

PF-05089771 Pain Rec 32 Adt Dec-10 Mar-11 Pfizer http://ClinicalTrials.gov/show/NCT01259882

Efficacy of Buprenorphine for Treatment of Acute Pain Phase IV: RCT (active), safety/efficacy study NCT01298297

Buprenorphine; Morphine

Acute Pain Rec 80 Child Adt Sen

Feb-10 Mar-11 Tehran University of Medical Sciences


A multi center, randomized, single blind study to evaluate the efficacy and safety of K-103-PA compared with indomethacin patch in the treatment of soft tissue pain Phase III: RCT (active), safety/efficacy study JapicCTI-101254

K-103-PA; ? Soft tissue pain Comp 340 Adt Sen

Sep-10 May-11 Kowa Co., Ltd. http://www.clinicaltrials.jp/user/cteSearch_e.jsp

45

Oxytocin and Arginine Vasopressin in Pain Relief Controlled trial (placebo), efficacy study NCT01328561

Placebo Analgesia

Rec 60 Adt Mar-11 ? Jan-11

National Institute of Mental Health (NIMH)


Other including CAM therapies Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB Observational: Prospective cohort study NCT01278355

Ear acupuncture Musculoskeletal Pain

Rec 40 Adt Jan-11 ? Jan-11

Samueli Institute for Information Biology


Miscellaneous observational studies Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab Observational: Prospective cohort study NCT01273519

RA; Ankylosing Spondylitis; Psoriatic Arthritis

Rec 240 Adt Sen

Jan-11 Jan-13 Abbott; Raffeiner GmbH


Finding Early Rheumatoid Arthritis Observational: Prospective cohort study NCT01341314

Joint Pain; Stiffness

Rec 200 Adt Sen

Jan-10 Jan-13 Brigham and Women's Hospital


Pain Sensitivity in Acute Inflammatory Pain Single Group Assignment, basic science study NCT01345877

Healthy Volunteers Are Studied

Comp 100 Adt Feb-10 Feb-11 University of Copenhagen; Norpharma A/S


46

B: RESEARCH RECOMMENDATIONS

Date published

Guideline Research recommendations (italicized recommendations have been taken verbatim from their respective publications)

June 2011 (Epub)

Ottawa panel evidence-based clinical practice guidelines for patient education programmes in the management of osteoarthritis (Brosseau & Ottawa panel members, 2011)

None

June 2011 How to explain central sensitization to patients with `unexplained' chronic musculoskeletal pain: Practice guidelines (Nijs et al, 2011)

None

June 2011 Ottawa Panel Evidence-Based Clinical Practice Guidelines for the Management of Osteoarthritis in Adults Who Are Obese or Overweight (Brosseau et al., 2011).

Research recommendations identified were:

• to examine other alternative therapies for weight reduction not included in review (which focused on diet and physical activity).

• to examine the differences in aerobic versus resistance training activity: this would help address more-specific activity prescriptions.

• to investigate how programs for managing OA in individuals with obesity can be optimized to ensure maximum benefits for various levels of knee OA disability.

May-June 2011

Practice guidelines for the management of low back pain (Guevara-López, et al., 2011)

None

May 2011 Joint Pain, Severe Cartilage Destruction, and Chondrolysis: Guidelines for Improving Diagnostic Differentiation and Clinical Management (SS-22) (Cole et al., 2011)

Unable to access full document

47

January 2011

Evidence-based clinical guidelines for the diagnosis, assesment and physiotherapy management of contacted (frozen) shoulder (Hanchard et al., 2011).

Future studies to:

• report interventions and comparators in sufficient detail to remove ambiguity;

• focus on a specific stage of contracted (frozen) shoulder e.g. ‘pain-predominant’ or ‘stiffness-predominant’, with pain taking primacy in ambiguous cases or to

• subgroup results by the condition’s stage.

• examine whether steroid injections are more efficacious in studies/subgroups of pain-predmoniant stage

• examine the efficacy of interventions in different care settings.

• consider conducting multi-centre trials to ensure sufficient sample sizes to allow precise effect to be calculated

• investigate physiotherapy modalities especially short wave diathermy, TENS, interferential and ultrasound, as part of therapeutic packages in care settings (rather than as standalone modalities).

December 2010

Health Care Guideline: Adult Low Back Pain (ICSI, 2010) None

December 2010

New guidelines for topical NSAIDs in the osteoarthritis treatment paradigm (Altman, 2010).

Unable to access full document

48

September 2010

Opioid Pharmacotherapy for Chronic Non-Cancer Pain in the United States: A Research Guideline for Developing an Evidence-Base (Chapman, et al., 2010).

There was recognition of the need for a strategic interdisciplinary approach with basic scientists and clinicians cooperating to resolve urgent issues and generate a comprehensive evidence base. Recommendations were suggested in 3 key areas:

• A research strategy for studying the effectiveness of long-term opioid pharmacotherapy • Improvements in evidence-generation methodology • Potential research topics for generating new evidence.

With regards to the effectiveness of opioids for chronic non-cancer pain two significant research gaps were identified:

1. the long-term benefit of opioid therapy 2. the incidence and severity of adverse drug events associated with opioid therapy

however, other research topics were also idenfied, including: • opioid induced hyperalgesia • opioid induced endocrine deficiencies • unexplained deaths • opioid pharmacotherapy and sleep • immunological impact of opioids • populations issues • opioid tolerance • benefits and risks of opioid rotation • interindividual variation in dose requirements • breakthrough pain • safe behaviours for patients using opioid medication • criteria for stable treatment effect and for treatment failure • combination opioid therapies and opioids combined with nonpharmacological interventions • clinical pharmacology of opioid medications

May/June 2010

Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery (Deer et al., 2010)

None

May 2010 Va/Dod Clinical Practice Guideline For Management Of Opioid Therapy For Chronic Pain (Clark et al., 2010)

“Future studies examining the results of clinical practice guidelines such as these may lead to the development of new practice-based evidence.” p.7

49

2010 American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain (AOA: Clinical Guideline Subcommittee on Low Back Pain, 2010)

None

January 2010

National guidelines for evaluating pain--Patients' legal right to prioritised health care at multidisciplinary pain clinics in Norway implemented 2009 (Hara & Borchgrevink, 2010)

None

January 2010

OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009 (Zhang et al., 2010).

None

November 2009

Guidelines for the proper use of epidural steroid injections for the chronic pain patient (Deer et al., 2009)

“Further studies are needed to properly evaluate interlaminar ESIs [epidural steroid injections] in the treatment of spinal stenosis and axial back pain syndromes. All future studies investigating ESIs as well as all neuroaxial procedures should employ fluoroscopy as well as radiopaque contrast to confirm proper needle placement and prevent intravascular and intrathecal injections. All physicians performing these procedures should be properly trained in the use of multiplanar fluoroscopy.” p.293

November 2009

Health Care Guideline: Assessment and Management of Chronic Pain (ICSI, 2009).

None

July 2009 Pharmacological management of persistent pain in older persons (American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons, 2009).

“Many other agents for specific pain syndromes may require caution in older persons and merit further research (e.g., glucosamine, chondroitin, cannabinoids, botulinum toxin, alpha-2 adrenergic agonists, calcitonin, vitamin D, bisphosphonates, ketamine) (low quality of evidence, weak recommendation).” p.1343

Summer 2009; also 2011

Over-the-counter pain management guidelines (Whittaker, 2009; 2011)

None

March 2009 Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain (Utah Department of Health, 2009)

None

February 2009

Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain (Chou, Fanciullo et al., 2009)

“Critical research gaps are present in methods for providing informed consent, effective components of opioid management plans, balancing risks and benefits of high-dose opioid therapy, utility of opioid rotation, and treatment of breakthrough pain. More research is also needed on how policies that govern prescribing and use of COT [chronic opioid therapy] affect clinical outcomes.” p.124

50

February 2009

Research Gaps on Use of Opioids for Chronic Noncancer Pain: Findings From a Review of the Evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline (Chou, Ballantyne, et al., 2009)

“Critical research gaps on use of opioids for chronic noncancer pain include: lack of effectiveness studies on long-term benefits and harms of opioids (including drug abuse, addiction, and diversion); insufficient evidence to draw strong conclusions about optimal approaches to risk stratification, monitoring, or initiation and titration of opioid therapy; and lack of evidence on the utility of informed consent and opioid management plans, the utility of opioid rotation, the benefits and harms specific to methadone or higher doses of opioids, and treatment of patients with chronic noncancer pain at higher risk for drug abuse or misuse.” p.147 Specifically highlighted in the discussion is the need for studies to:

• determine effectiveness and long-term outcomes in less selective populations to evaluate benefits & harms.

• clarify optimal opioid dosing strategies • identify optimal approaches in initiating and titrating opioid rotation • determine if and how benefits and harms associated with methoadone or other specific

opioids differ • validate diagnostic accuracy of risk assessment and monitoring instruments across different

settings using standardised definitions of clinically aberrant drug related behaviours: and to establish whether these instruments improve outcomes.

• develop and validate instruments to assess potential benefits and opioid-related adverse effects alongside aberrant drug related behaviours.

• quantify risks associated high dose opioids • evaluate if high dose opioids are associated with different or unique harms compared to low

dose opioids • determine whether patient characteristics can predict lack of response to high dose opioids

other areas identified as ‘research gaps’ either were lacking evidence: • benefits and harms of opioid management plans • different methods of providing informed consent • driving and work-related risks in patients prescribed chronic opioid therapy

or had no current evidence base: • benefits and harms of chronic opioid therapy for chronic noncancer pain during pregnancy • how policies related to opioid prescribing affect outcomes

51

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Documents

Pain Horizon Scan June 2011 - Keele University